MAUDE Adverse Event Report: RESPIRONICS, INC. SIMPLYGO; PORTABLE OXYGEN CONCENTRATOR

Model Number	1068987
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
H3 other text : device not returned to manufacturer.
Event or Problem Description
The manufacturer received information regarding a simplygo device.The reporter alleges the patient passed away while awaiting the return of the simplygo unit.The unit was sent for repair-to-repair authority since spring 2022 for a sieve canister kit and inlet filter.The family of the patient did not state the device was the cause of the patient expiring.The cause of the patient's death was not provided by the reporter.The device was sent for service due to the sieve bed "went bad".The relative of the patient brought the device to the pharmacy for repair/replacement in (b)(6) 2022.The patient passed in (b)(6) 2022 (exact date not provided).The relative of the patient thinks the patient passed away because the patient did not have the simplygo device.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: SIMPLYGO
• Common Device Name: PORTABLE OXYGEN CONCENTRATOR
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18962118
• Report Number: 2518422-2024-14880
• Device Sequence Number: 20824639
• Product Code: CAW
• UDI-Device Identifier: 00606959005723
• UDI-Public: 00606959005723
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 1068987
• Device Catalogue Number: 1068987
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown